TINTED RADIANCE MOISTURIZER BROAD SPECTRUM SPF 32- zinc oxide and titanium dioxide cream

Tinted Radiance Moisturizer Broad Spectrum SPF 32 by

Drug Labeling and Warnings

Tinted Radiance Moisturizer Broad Spectrum SPF 32 by is a Otc medication manufactured, distributed, or labeled by Allure Labs Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients:

Zinc Oxide - 6.0%

Titanium Dioxide - 4.5%

PURPOSE

Purpose:

Sunscreen

INDICATIONS & USAGE

Uses:

• Helps prevent sunburn.
• If used as directed with other sun protection measures, decreases the risk of skin cancer and  early skin aging  caused by the sun.
  

WARNINGS AND PRECAUTIONS

Warning:

• For external use only.
  

DO NOT USE

Do not use:

• On damaged or broken skin.
  

WHEN USING

When using this products:

• Keep out of eyes.
• Rinse with water to remove.
  

STOP USE

Stop use and ask a doctor:

• If rash occurs.
  

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children:

• If swallowed, get medical help or contact a Poison Control Center right away.
  

DOSAGE & ADMINISTRATION

For Sunscreen use:

• Apply liberally 15 minutes before sun exposer.
• Use a water resistant sunscreen if swimming or sweating.
• Reapply at least every 2 hours.
• Children under 6 months: ask a doctor.
• Sun protection measures.Spending time in the sun increase your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a Broad Spectrum SPF of 15 or higher and other sun protection measures including:
•  limit time in the sun, especially from 10 a.m. - 2 p.m.
• wear long sleeve shirts, pants, hats and sunglasses.

INACTIVE INGREDIENT

Water, Cyclopentasiloxane, C12-15 Alkyl Benzoate, Dimethicone Ployglyceryl-3, Polydimethylsiloxyethyl Dimethicone, Dimethicone/PEG -10/15 Crosspolymer, Stearic Acid, Aluminum Hydroxide, Sodium Chloride, Glycerin, Magnolia officinallis Bark Extract, Ectoin, Caprylyl Glycol, Teprenone, Sodium Hyaluronate, Vitis Vinifera, (Grape) seed extract, Tetrahexyldecyl Ascorbate, Ergothioneine, Tocopheryl Acetate, Tocopherol, Maltodextrin, Lecithin, Ethylhexyl Palmitate Caprylyc/Capric Triglyceride, PEG/PPG-18/18 Dimethicone, Polyglycerin-3 Crosspolymer, Hexyl Laurate, Cyclohexasiloxane, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Dimethicone/Venyl Dimethicone Crosspolymer, Polyglyceryl-4 Isostearate, Cetyl PEG/PPG-10/1 Dimethicone, Silica Dimethyl Sylilate, Triethoxycaprylylsilane, Phenoxyethanol, Ethylhexylglycerin, Butylene Glycol, Hexylene Glycol Fragrance, Mica, Silaca, May contains: Iron Oxide.

PRINCIPAL DISPLAY PANEL

Dist. By.

EVER LLC

Sausalito, CA 94965

INGREDIENTS AND APPEARANCE

TINTED RADIANCE MOISTURIZER BROAD SPECTRUM SPF 32 
zinc oxide and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62742-4085
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	60 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	45 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
DIMETHICONE (UNII: 92RU3N3Y1O)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
GLYCERIN (UNII: PDC6A3C0OX)
MAGNOLIA OFFICINALIS BARK (UNII: 5M609NV974)
ECTOINE (UNII: 7GXZ3858RY)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
TEPRENONE (UNII: S8S8451A4O)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
VITIS VINIFERA SEED (UNII: C34U15ICXA)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
ERGOTHIONEINE (UNII: BDZ3DQM98W)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TOCOPHEROL (UNII: R0ZB2556P8)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62742-4085-2	1 in 1 CARTON	04/28/2016
1	NDC: 62742-4085-1	30 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	04/28/2016

Labeler - Allure Labs Inc (926831603)